UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 15, 2012
DIADEXUS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 0-26483 | 94-3236309 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
349 Oyster Point Boulevard, South San Francisco, California 94080 | ||||
(Address of Principal Executive Offices) (Zip Code) |
Registrants telephone number, including area code: (650) 246-6400
N/A
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. | Results of Operations and Financial Condition. |
On March 15, 2012, diaDexus, Inc. (the Company) issued a press release announcing financial results for its fourth quarter and full fiscal year ended December 31, 2011. A copy of the press release is furnished as Exhibit 99.1 to this report.
The information furnished pursuant to this Item 2.02 of this report, including the exhibit attached hereto, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered filed or incorporated by reference therein.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press release |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
diaDexus, Inc. | ||||
(Registrant) | ||||
Date: March 15, 2012 | ||||
By: | /s/ Jean-Frédéric Viret | |||
Jean-Frédéric Viret | ||||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press release |
Exhibit 99.1
diaDexus, Inc. Reports 2011 Fourth Quarter and Year-End Financial Results
Six consecutive quarters of year-over-year revenue growth
SOUTH SAN FRANCISCO, Calif., March 15, 2012 diaDexus, Inc. (OTC Bulletin Board: DDXS.OB), a company focused on the development and commercialization of proprietary cardiovascular diagnostic products, today announced financial results for the 2011 fourth quarter and year-end.
Fourth quarter 2011
Total revenues for the 2011 fourth quarter were $4.9 million, a 48% increase over $3.3 million for the fourth quarter of 2010, representing the highest quarterly revenues in the history of the company. Total expenses for the quarter were $5.8 million, unchanged from the fourth quarter of 2010. The companys net loss for the quarter was $1.0 million compared to a $2.1 million net loss in the fourth quarter of 2010. The decrease in net loss for the quarter was largely due to a $1.6 million increase in fourth quarter sales of the PLAC® Test for Lp-PLA2 versus the comparable 2010 period. Net cash used in operating activities for the fourth quarter of 2011 was $1.6 million versus $2.8 million for the same period the year prior.
Year-end 2011
Total revenues for the 12-month period ended December 31, 2011 were $16.4 million compared to $11.8 million for 2010. This 39% increase was due to accelerated demand for the companys PLAC® Test for Lp-PLA2 and represents record annual revenues. Total operating expenses for 2011 were $24.2 million compared to total operating expenses of $20.4 million in 2010. The company reduced its net loss to $7.5 million for the year ended December 31, 2011, compared to a net loss of $8.4 million in 2010. Net cash used in operating activities was $6.7 million in 2011 versus $7.5 million in 2010, also primarily a result of higher revenues.
Cash and investments at December 31, 2011 were $17.2 million compared to $20.4 million at December 31, 2010.
Guidance
diaDexus maintained its guidance for 2012 total revenues at $20 million to $21 million, projecting year-over-year growth of approximately 26% compared to 2011. The company believes it will use approximately $6 million in operations. Future financing needs will depend on the companys ability to increase the rate of adoption for the companys products by physicians, progress in achieving additional positive coverage decisions from insurers for the PLAC® Test for Lp-PLA2, and commercialization needs.
diaDexus had an outstanding fiscal 2011, the strongest fourth quarter in the history of the company, and grew revenues to a record of $16.4 million, said Brian Ward, Ph.D.,
diaDexus Chief Executive Officer. We are gaining strong momentum with acceptance of the PLAC Lp-PLA2 Mass testing as an essential biomarker that aids physicians by indicating the risk of cardiovascular heart disease and stroke in the United States. With the launch of diaDexus new PLAC® Test for Lp-PLA2 Activity in Europe in the first quarter of 2012, we are now positioned for further long-term sales momentum. The recent hire of Jean Viret as our Chief Financial Officer completes our executive management team, and allows us to maintain our sales momentum and deliver increased value to our shareholders.
Webcast
diaDexus will host a webcast on Thursday, March 15 at 1:15 PM PDT (4:15 PM EDT) to discuss the 2011 fourth quarter and year-end financial results. The webcast may be accessed via the companys website at www.diadexus.com/webcast.
About diaDexus, Inc.
diaDexus, Inc., based in South San Francisco, California, is focused on the development and commercialization of proprietary in vitro diagnostic products addressing unmet needs in cardiovascular disease. The companys PLAC® Test for Lp-PLA2 is the only blood test cleared by the FDA to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. For more information, please visit the companys website at www.diaDexus.com
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the companys plans, objectives, expectations and intentions with respect to future financial results, operations and products and other statements that are not historical in nature, particularly those that use terminology such as will, potential, could, can, believe, intends, continue, plans, expects, estimates or comparable terminology. Forward-looking statements are based on current expectations and assumptions, and entail various known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to diaDexus that could cause actual results to differ materially from those expressed in such forward-looking statements include diaDexus ability to submit a new 510(k) application for, and obtain FDA clearance of, its new automated Lp-PLA2 Activity test; diaDexus ability to gain acceptance of its PLAC® Test products in the marketplace, including its ability to demonstrate that treatment of individuals based on their Lp-PLA2 levels improves clinical outcomes in prospective clinical studies; diaDexus high degree of customer concentration, including the downward pressure that its largest customers may be able to exert on its product pricing; diaDexus relationship with key customers, including
GlaxoSmithKline, the licensor of Lp-PLA2; diaDexus reliance on a sole source third party manufacturer to manufacture and supply diaDexus PLAC® ELISA Test; third party payors acceptance of and reimbursement for the PLAC® Test; diaDexus ability to develop and commercialize new products and services; various risks associated with the international expansion of diaDexus business; diaDexus ability to successfully launch and commercialize the PLAC® Test for Lp-PLA2 Activity in Europe, and its dependence on its distributors for foreign sales of that test; diaDexus ability to initiate and continue to manufacture the PLAC® Test for Lp-PLA2 Activity at its facility in South San Francisco, California; the adequacy of diaDexus intellectual property rights; diaDexus ability to satisfy its obligations under its license agreements, to maintain its license rights under those license agreements and to enter into any necessary licenses on acceptable terms; diaDexus ability to attract, retain and motivate qualified personnel; the effects of U.S. and foreign government regulations and diaDexus ability to comply with such regulations; diaDexus limited revenue and cash resources; and diaDexus significant corporate expenses, including real estate lease liabilities and expenses associated with being a public company. Additional factors that could cause diaDexus results to differ materially from those described in the forward-looking statements can be found in diaDexus most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and other reports filed with the Securities and Exchange Commission, and available at the SECs web site at www.sec.gov. The information set forth herein speaks only as of the date hereof, and diaDexus disclaims any intention and does not assume any obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
Contacts: | Jean Viret, CFO | |
Direct 650-246-6403 | ||
Email: jviret@diadexus.com | ||
Shari Annes, IR | ||
Direct 650-888-0902 | ||
Email: sannes@annesassociates.com |
Tables to follow
DIADEXUS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share data)
(unaudited)
Three Months Ended December 31, |
Years Ended December 31, |
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2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues: |
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License revenue |
$ | 76 | $ | 76 | $ | 305 | $ | 305 | ||||||||
Royalty revenue |
996 | 1,005 | 3,859 | 3,632 | ||||||||||||
Product sales |
3,646 | 2,058 | 11,738 | 7,132 | ||||||||||||
Product sales to related party |
161 | 160 | 482 | 681 | ||||||||||||
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Total revenues |
4,879 | 3,299 | 16,384 | 11,750 | ||||||||||||
Operating costs and expenses: |
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Product costs |
1,628 | 1,270 | 5,404 | 4,652 | ||||||||||||
Sales and marketing |
852 | 1,102 | 4,143 | 5,138 | ||||||||||||
Research and development |
923 | 1,351 | 5,138 | 4,935 | ||||||||||||
General and administrative |
2,438 | 2,114 | 9,544 | 5,629 | ||||||||||||
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Total operating costs and expenses |
5,841 | 5,837 | 24,229 | 20,354 | ||||||||||||
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Loss from operations |
(962 | ) | (2,538 | ) | (7,845 | ) | (8,604 | ) | ||||||||
Interest income, interest expense and other income (expense), net: |
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Interest income |
12 | 15 | 56 | 40 | ||||||||||||
Interest expense |
(102 | ) | 207 | 288 | (149 | ) | ||||||||||
Other income (expense), net |
10 | (2 | ) | 19 | 42 | |||||||||||
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Loss before income tax |
(1,042 | ) | (2,318 | ) | (7,482 | ) | (8,671 | ) | ||||||||
Income tax benefit (provision) |
| 231 | (1 | ) | 226 | |||||||||||
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Net loss |
$ | (1,042 | ) | $ | (2,087 | ) | $ | (7,483 | ) | $ | (8,445 | ) | ||||
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Basic and diluted net loss per share: |
$ | (0.02 | ) | $ | (0.04 | ) | $ | (0.14 | ) | $ | (0.25 | ) | ||||
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Weighted average shares used in computing basic and diluted net loss per share |
53,067,045 | 53,067,057 | 53,067,052 | 33,594,033 | ||||||||||||
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DIADEXUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31, 2011 |
December 31, 2010 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 10,484 | $ | 20,394 | ||||
Short-term marketable securities |
6,492 | | ||||||
Accounts receivable |
2,408 | 1,543 | ||||||
Receivable from related party |
| 175 | ||||||
Inventories |
117 | 105 | ||||||
Restricted cash |
400 | | ||||||
Assets held for sale |
304 | 308 | ||||||
Prepaid expenses and other current assets |
975 | 1,046 | ||||||
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Total current assets |
21,180 | 23,571 | ||||||
Long-term investments |
250 | | ||||||
Restricted cash |
1,400 | 1,800 | ||||||
Property and equipment, net |
1,350 | 580 | ||||||
Other long-term assets |
175 | 128 | ||||||
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Total assets |
$ | 24,355 | $ | 26,079 | ||||
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
$ | 882 | $ | 445 | ||||
Deferred revenues, current portion |
331 | 305 | ||||||
Deferred rent, current portion |
| 103 | ||||||
Unfavorable lease obligations |
492 | 363 | ||||||
Notes payable, current portion |
372 | | ||||||
Accrued and other current liabilities |
2,469 | 1,930 | ||||||
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Total current liabilities |
4,546 | 3,146 | ||||||
Long-term deferred rent |
266 | 52 | ||||||
Non-current portion of unfavorable lease obligation |
3,063 | 3,555 | ||||||
Non-current portion of deferred revenue |
530 | 835 | ||||||
Non-current portion of notes payable |
4,526 | | ||||||
Other long term liabilities |
284 | 646 | ||||||
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Total liabilities |
13,215 | 8,234 | ||||||
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Stockholders equity: |
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Preferred stock |
| | ||||||
Common stock |
531 | 531 | ||||||
Additional paid-in capital |
205,557 | 204,774 | ||||||
Accumulated other comprehensive loss |
(5 | ) | | |||||
Accumulated deficit |
(194,943 | ) | (187,460 | ) | ||||
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Total stockholders equity |
11,140 | 17,845 | ||||||
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Total liabilities and stockholders equity |
$ | 24,355 | $ | 26,079 | ||||
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# # #